Opportunity Information: Apply for PAR 19 079
Molecular and Genetic Characterization of Inborn Errors of Immunity (R21 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) discretionary grant opportunity (Funding Opportunity Number PAR-19-079; CFDA 93.855) focused on early-stage, exploratory research that clarifies how specific genetic changes cause inborn errors of immunity, also known as primary immunodeficiency diseases. The central goal is to push beyond gene discovery by supporting experimental validation and functional characterization of variants found in either coding regions (that alter proteins) or non-coding regions (that can disrupt gene regulation). Projects supported under this announcement are expected to explain, in a mechanistic and biologically convincing way, how a candidate variant leads to immune dysfunction at the molecular, cellular, and immunological levels.
This FOA emphasizes research that turns genetic findings into evidence-based disease mechanisms. In practical terms, that means applicants are encouraged to move from a suspected disease-associated variant to demonstration of its functional impact using appropriate experimental systems. That could include showing how a variant alters gene expression, protein function, signaling pathways, cell development, or immune responses, and then linking those disruptions to clinically relevant immune phenotypes. The intended outcome is a clearer genetic and mechanistic foundation for these disorders, which directly supports improved diagnosis and prognosis and helps create a pathway toward precision therapeutics (for example, identifying actionable targets, rationally selecting existing drugs, or informing development of new interventions).
The mechanism is an NIH R21, which is typically used for innovative, higher-risk studies that generate strong preliminary evidence, new methods, or proof-of-concept data that can later be expanded under larger awards. The listed award ceiling is $200,000. As indicated by the title, clinical trials are not allowed under this specific opportunity, so the work should be preclinical or mechanistic rather than interventional studies in human participants. Human data can still be relevant in many R21 contexts (for example, using de-identified samples, observational data, or ex vivo analyses), but the FOA framing makes clear that applicants should not propose a clinical trial as defined by NIH.
Eligibility is broad and includes many organization types, reflecting an interest in drawing strong proposals from universities, medical and research institutions, nonprofits, government entities, and industry. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education when specified); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and non-U.S. entities (foreign organizations). This inclusive eligibility structure supports participation by a wide range of research and community-serving institutions, including those serving underrepresented populations and those located outside the continental United States.
The opportunity was created on November 26, 2018, and the original closing date listed in the source data is January 7, 2022. Overall, this FOA is designed to accelerate rigorous mechanistic studies that connect genetic variants to immune system defects, strengthening the evidence base needed for more accurate molecular diagnosis and for future development of targeted, precision approaches to treatment for patients with inborn errors of immunity.Apply for PAR 19 079
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Molecular and Genetic Characterization of Inborn Errors of Immunity (R21 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
- This funding opportunity was created on 2018-11-26.
- Applicants must submit their applications by 2022-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled Molecular and Genetic Characterization of Inborn Errors of Immunity (R21 Clinical Trial Not Allowed).
Which agency is offering this grant?
This is a discretionary grant opportunity from the National Institutes of Health (NIH).
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is PAR-19-079.
What is the CFDA number associated with this opportunity?
The opportunity lists CFDA 93.855.
What type of NIH grant mechanism is this?
This opportunity uses the NIH R21 mechanism, which is commonly used for early-stage, exploratory, and potentially higher-risk research intended to produce proof-of-concept data, strong preliminary evidence, or new methods that can be expanded later under larger awards.
What is the main scientific focus of this FOA?
The FOA focuses on early-stage, exploratory research to clarify how specific genetic changes cause inborn errors of immunity, also known as primary immunodeficiency diseases.
What is the central goal of the projects NIH wants to support?
The central goal is to go beyond gene discovery by supporting experimental validation and functional characterization of candidate genetic variants, and to explain in a mechanistic and biologically convincing way how those variants lead to immune dysfunction at the molecular, cellular, and immunological levels.
Does this FOA support gene discovery alone?
No. The FOA emphasizes moving beyond identifying candidate genes or variants. Projects are expected to provide evidence-based mechanisms showing how a candidate variant actually contributes to disease-related immune dysfunction.
What kinds of genetic variants are in scope?
The FOA includes variants in coding regions (which can alter proteins) and non-coding regions (which can disrupt gene regulation).
What does “functional characterization” mean in the context of this FOA?
In this FOA, functional characterization means experimentally demonstrating the impact of a suspected disease-associated variant using appropriate experimental systems. Examples described include showing how a variant affects gene expression, protein function, signaling pathways, cell development, or immune responses, and linking those disruptions to clinically relevant immune phenotypes.
What level of explanation is NIH expecting for the mechanism of disease?
Projects are expected to explain, in a mechanistic and biologically convincing way, how a candidate variant leads to immune dysfunction across multiple levels, including molecular, cellular, and immunological effects.
How is “immune dysfunction” expected to be addressed in proposed studies?
Based on the FOA description, applicants should connect a candidate variant to measurable disruptions such as altered gene regulation, protein activity, signaling, immune cell development, or immune responses, and then relate those disruptions to disease-relevant immune phenotypes.
Why is the FOA emphasizing mechanistic studies?
The FOA is designed to strengthen the evidence base that connects genetic variation to immune system defects, supporting improved diagnosis and prognosis and helping build a pathway toward precision therapeutics by identifying actionable targets or informing development or selection of interventions.
What outcomes does this FOA aim to enable in the long term?
The intended outcome is a clearer genetic and mechanistic foundation for inborn errors of immunity that supports more accurate molecular diagnosis, better prognosis, and a pathway toward precision therapeutics (including actionable targets, rational selection of existing drugs, or informing development of new interventions).
Are clinical trials allowed under this funding opportunity?
No. As indicated by the title, this FOA is Clinical Trial Not Allowed. The proposed work should be preclinical or mechanistic rather than an interventional study in human participants.
Can human data or human samples still be used if clinical trials are not allowed?
The description notes that human data can still be relevant in many R21 contexts, such as using de-identified samples, observational data, or ex vivo analyses. However, applicants should not propose a clinical trial as defined by NIH.
What is the award ceiling listed for this opportunity?
The listed award ceiling is $200,000.
Who is eligible to apply?
Eligibility is broad and includes many organization types, including universities and colleges, medical and research institutions, nonprofits, government entities, and industry. Eligible applicants include:
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Federally recognized Native American tribal governments
- Tribal organizations that are not federally recognized
- Public housing authorities / Indian housing authorities
- Nonprofits with or without 501(c)(3) status (excluding institutions of higher education when specified)
- For-profit organizations other than small businesses
- Small businesses
- Eligible federal agencies
- Faith-based or community-based organizations
- U.S. territories or possessions
- Regional organizations
- Non-U.S. entities (foreign organizations)
Does the FOA specifically encourage applications from institutions serving underrepresented populations?
Yes. The FOA explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs), among others.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The FOA lists non-U.S. entities (foreign organizations) as eligible.
Are for-profit organizations eligible?
Yes. The eligibility list includes for-profit organizations other than small businesses and also includes small businesses.
When was this funding opportunity created?
The opportunity was created on November 26, 2018.
What closing date is listed in the provided information?
The original closing date listed in the source data is January 7, 2022.
What does this FOA mean by moving “from a suspected disease-associated variant” to stronger evidence?
It means taking a candidate variant that appears linked to disease and then using experiments to demonstrate its functional impact (for example, effects on gene regulation, protein function, signaling, cell development, or immune responses) and connecting those effects to clinically relevant immune phenotypes.
What kinds of biological levels should proposed projects address?
The FOA expects mechanistic explanations spanning molecular, cellular, and immunological levels to show how a genetic variant produces immune dysfunction.
How does this FOA connect mechanistic research to patient benefit?
By building a clearer genetic and mechanistic foundation for inborn errors of immunity, the FOA supports improved diagnosis and prognosis and helps lay groundwork for precision therapeutics, such as identifying actionable targets and informing future intervention development or selection.
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